510(k) K955472

ACE HUMERUS & RADIUS PLATES by Ace Medical Co. — Product Code HRS

K955472 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "ACE HUMERUS & RADIUS PLATES". The FDA issued a decision of Substantially Equivalent on April 1, 1996. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ace Medical Co. has at least 10 other 510(k) clearances on record.